Monday, August 15, 2022

Axcella Therapeutics (AXLA)
2Q Included The First of Two Phase 2 Data Announcements

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

2Q Included Long COVID-19 Data Announcement and An Increase In Cash.  Axeclla reported a loss of $21.3 million or $(0.40) per share, compared with our estimate of $19.4 million or $(0.47) per share.  During the quarter, the company raised about $25 million through a direct stock offering, bringing cash and marketable securities to $44.4 million as of June 30.  The highlight of the quarter, in our opinion, was the announcement of Phase 2a data in Long COVID-19.

Phase 2a Data Was Encouraging.  The company recently announced positive data from its Phase 2a trial testing AXA1125 in Long COVID-19.  These data showed statistically significant improvements in several measures of physical and mental fatigue.  The company reiterated plans to meet with the FDA to discuss the design of the next clinical test during the coming months….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Ayala Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update

Research, News, and Market Data on Ayala Pharmaceuticals

August 15, 2022

Interim data from Part A of the RINGSIDE study
demonstrated substantial initial anti-tumor activity for AL102 as a single
agent and supports continued development

More advanced and comprehensive data set from RINGSIDE to be
presented at ESMO

REHOVOT, Israel and WILMINGTON, Del., Aug. 15, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced second-quarter 2022 financial results and provided a corporate update.

“We continue to make considerable progress across our pipeline, and we were particularly excited to announce interim results from the ongoing Phase 2/3 RINGSIDE trial evaluating AL102 in desmoid tumors. Although early, the results showed substantial initial anti-tumor activity and a favorable side effect profile,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Based on these positive results, our efforts are focused on finalizing the Part A of the study shortly followed by immediate initiation of Part B. For AL101, we were pleased with the latest interim results from the ACCURACY trial presented at ASCO, which demonstrated anti-tumor monotherapy activity and evidence of improved progression-free survival (PFS) in patients with recurrent/metastatic ACC.”

Second-quarter 2022
and Recent Business Highlights

• In July, announced positive interim data
  from Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid
  tumors: Data showed tumor shrinkage in substantially all patients who were evaluable at 16 weeks. AL102 was well tolerated at all three dosing regimens with no dose-limiting toxicities and no Grade 4/5 adverse events. The results from Part A will be used to determine the dose of AL102 to be evaluated in Part B of RINGSIDE, the randomized portion of the study, which Ayala is on track to initiate in 3Q 2022. More advanced and comprehensive data from RINGSIDE is expected to be presented at ESMO.
• Data on AL101 in adenoid cystic carcinoma
  (ACC) presented at ASCO 2022 Annual Meeting: In a poster at ASCO, the company provided an update from the 4mg and 6 mg AL101 cohorts in the ACCURACY study of AL101, a selective gamma-secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations. An overall disease control rate of 66.7% was observed. The median PFS in each of the 4mg and 6mg dose cohorts was 3.7 months and 6.7 months among the patients who had a partial response.

Upcoming Milestones

• More
  advanced data from the RINGSIDE trial in desmoid tumors: Ayala expects to present a more comprehensive data set from Part A of the RINGSIDE trial of AL102 at ESMO.
• Initiation
  of Part B of the RINGSIDE trial: Part B will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The primary endpoint will be PFS with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
• Initiate
  Phase 2 clinical trial evaluating AL102 in T-cell acute lymphoblastic
  leukemia (T-ALL): Ayala plans to begin an investigator-initiated Phase 2 clinical trial evaluating AL102 in R/R T-ALL around year-end.

Second-Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $20.1 million as of June 30, 2022.

Collaboration Revenue: Collaboration revenue was $38 thousand for the second quarter of 2022, as compared to $761 thousand for the corresponding quarter in 2021.

R&D Expenses: Research and development expenses were $5.6 million for the second quarter of 2022, compared to $8.1 million for the corresponding quarter in 2021. The decrease is mainly due to the winding down of the ACCURACY study.

G&A Expenses: General and administrative expenses were $2.3 million for the second quarter of 2022, compared to $2.5 million for the second quarter of 2021.

Net Loss: Net loss was $8.2 million for the second quarter of 2022, resulting in basic and diluted net loss per share of $0.54. This compares with a net loss of $10.8 million for the second quarter of 2021 or basic and diluted net loss per share of $0.75 for that quarter.

For further details on the company’s financial results, refer to form Quarterly Report on Form 10-Q for the three months ended June 30, 2022, filed with the SEC on August 15, 2022.

About Ayala Pharmaceuticals

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including desmoid tumors, adenoid cystic carcinoma and T-cell acute lymphoblastic leukemia (T-ALL). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602

[email protected] 

Ayala Pharmaceuticals:
+1-857-444-0553

[email protected] 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, our participation at scientific or medical conferences, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2022 filed with the U.S. Securities and Exchange Commission (SEC) on August 15, 2022 and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

AYALA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts)
		June 30,				December 31,
		2022				2021
		(Unaudited)
CURRENT ASSETS:
Cash and Cash Equivalents		$	20,059			$	36,982
Short-term Restricted Bank Deposits			111				122
Trade Receivables			262				–
Prepaid Expenses and other Current Assets			2,322				2,636
Total Current Assets			22,754				39,740
LONG-TERM ASSETS:
Other Assets		$	231			$	267
Property and Equipment, Net			1,039				1,120
Total Long-Term Assets			1,270				1,387
Total Assets		$	24,024			$	41,127
LIABILITIES AND STOCKHOLDERS’ EQUITY:
CURRENT LIABILITIES:
Trade Payables		$	3,254			$	3,214
Other Accounts Payables			2,993				3,258
Total Current Liabilities			6,247				6,472
LONG TERM LIABILITIES:
Long-term Rent Liability			414				497
Total Long-Term Liabilities		$	414			$	497
STOCKHOLDERS’ STOCKHOLDERS’ EQUITY:
Common Stock of $0.01 par value per share; 200,000,000 shares authorized at
December 31, 2021 and June 30, 2022; 14,503,743 and 14,080,383 shares issued at June 30, 2022 and December 31, 2021, respectively; 13,984,662 and 13,956,035 shares outstanding at June 30, 2022 and December 31, 2021, respectively		$	139			$	139
Additional Paid-in Capital			146,602				145,160
Accumulated Deficit			(129,378	)			(111,141	)
Total Stockholders’ Equity			17,363				34,158
Total Liabilities and Stockholders’ Equity		$	24,024			$	41,127

 

AYALA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except share & per share amounts)
		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2022				2021				2022				2021
Revenues from licensing agreement and others		$	38			$	761			$	496			$	1,735
Cost of services			(38	)			(761	)			(406	)			(1,735	)
Gross profit			—				—				90				—
Operating expenses:
Research and development			5,580				8,121				13,083				15,046
General and administrative			2,260				2,536				4,701				4,839
Operating loss			(7,840	)			(10,657	)			(17,694	)			(19,885	)
Financial Income (Loss), net			(156	)			(22	)			(140	)			(114	)
Loss before income tax			(7,996	)			(10,679	)			(17,834	)			(19,999	)
Taxes on income			(214	)			(162	)			(403	)			(410	)
Net loss			(8,210	)			(10,841	)			(18,237	)			(20,409	)
Net Loss per share attributable to common stockholders, basic and diluted		$	(0.54	)		$	(0.75	)		$	(1.19	)		$	(1.46	)
Weighted average common shares outstanding, basic and diluted			15,312,766				14,417,423				15,306,823				13,954,676

 

PsyBio Therapeutics Strengthens IP Portfolio through Filing of Data to Support Previously Submitted Provisional Biosynthetic Production Patent Application

Research, News, and Market Data on PsyBio

Biosynthetic Production covers
Methylated Tryptamine Derivatives including DMT and 5-MeO-DMT

OXFORD, Ohio and DENVER, Aug. 11, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB), (OTCQB: PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company focused upon discovery and development of novel, psycho-targeted therapeutics to potentially improve mental and neurological health, today is announcing the filing of data to support the conversion of a previously submitted provisional patent covering the biosynthetic production of methylated tryptamine derivatives including 
N,N-dimethyltryptamine (“DMT“) and 5-methoxy-N,N-dimethyltryptamine (”
5-MeO-DMT“) as well as other related products.

“We are proud of the strength of our intellectual property portfolio, safeguarding our advancement of biosynthetic production of psycho-targeted molecules. This most recent filing of data extends our coverage to include DMT and 5-MeO-DMT,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “While these methylated tryptamine derivatives are well known, this filing covers numerous novel compounds that we expect will allow us to proceed with clinical development and build on our work to potentially improve mental and neurological healthcare for patients.”

The patent information submitted includes data concerning host strains, production methodology, and processes of production that support and allow PsyBio’s novel methodology to be successful.

“PsyBio continues to demonstrate its leadership in the biosynthetic development field through our continued commitment to strengthen our intellectual property portfolio, while also promoting scientific and methodologic advancements in the field,” stated Evan Levine, PsyBio’s Chief Executive Officer. “Intellectual property protection is paramount for our Company and our shareholders.”

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof.  The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.

Cautionary Note Regarding
Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (”
forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to proceed with clinical development and to build on efforts to potentially improve mental and neurological healthcare for patients; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the success of PsyBio’s novel methodology; the ability of PsyBio to build and protect its intellectual property portfolio of novel drug candidates; the ability of PsyBio to launch clinical trials; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: the filing will extend intellectual property protection coverage to include DMT and 5-MeO-DMT; the patent information submitted will support and allow PsyBio’s novel methodology to be successful; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file one or more investigational new drug applications with the United States Food and Drug Administration (“FDA“); PsyBio will be successful in obtaining all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (the
“TSXV“) has neither approved nor disapproved the contents of
this news release. Neither the TSXV nor its Regulation Services Provider (as
that term is defined in the policies of the TSXV) accepts responsibility for
the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

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Ocugen CEO to Present at H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference

Research, News, and Market Data on Ocugen

August 12, 2022

MALVERN, Pa., Aug. 12, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen, will deliver a virtual presentation at the 
H.C. Wainwright 2^nd Annual Ophthalmology Virtual
Conference on August 17.

A video webcast of the presentation will be available on demand beginning at 7:00 a.m. ET on August 17, 2022 for those registered for the event and will be available on the events page of the Ocugen 
investor site. The webcast replay will be archived for 90 days following the event.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995, which are subject to
risks and uncertainties. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or
other words that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Such statements are subject to numerous
important factors, risks, and uncertainties that may cause actual events or
results to differ materially from our current expectations. These and other
risks and uncertainties are more fully described in our periodic filings with
the Securities and Exchange Commission (SEC), including the risk factors
described in the section entitled “Risk Factors” in the quarterly and annual
reports that we file with the SEC. Any forward-looking statements that we make
in this press release speak only as of the date of this press release. Except
as required by law, we assume no obligation to update forward-looking
statements contained in this press release whether as a result of new
information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
[email protected]

 

 

Axcella Reports Second Quarter Financial Results and Provides Business Update

Research, News, and Market Data on Axcella Therapeutics

August 12, 2022 at 7:30 AM EDT

• Announced Statistically Significant Clinical
  Improvement in Fatigue in the Phase 2A Long COVID Trial Topline data

• NASH Trial interim Data
  Expected in Late Q3 2022

• Company to Host Conference Call
  at 8:30 a.m. ET today

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 12, 2022– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the second quarter ended 
June 30, 2022 and provided a business update.

“Axcella has been a leader in clinical development in Long COVID. We continued this leadership through the second quarter as we advanced the development of our two clinical programs for AXA1125. Our Phase 2A trial of Long COVID in collaboration with 
Oxford University
 is now complete. The results were extremely encouraging and showed that administration of AXA1125 to patients significantly reduced mental and physical fatigue,” said  Bill Hinshaw , President and Chief Executive Officer of Axcella. “Since reporting our data last week, we have received extremely positive feedback from our community of physicians and patients regarding their excitement about the further development of this therapeutic and its potential to benefit patients once it reaches the clinic. In addition, we continue to participate in investors meetings to get the story of the company out to the wider investment community.”

Financial Results

Cash Position: As of 
June 30, 2022, cash, cash equivalents, and marketable securities totaled 
$44.4 million
, compared to 
$55.0 million
 as of 
December 31, 2021. In 
March 2022, the Company received approximately 
$25.0 million
 in gross proceeds from a registered direct offering of common stock. Axcella expects that its current cash balance will be sufficient to meet its operating needs into the first quarter of 2023, provided that, if the Company is unable to satisfy the cash covenants contained in its loan and security agreement with SLR Investment Corp., and SLR Investment Corp. seeks immediate repayment of the loan in full, the Company believes that its cash and cash equivalents will be sufficient to fund its operations into the fourth quarter of 2022.

R&D Expenses: Research and development expenses for the quarter and six months ended 
June 30, 2022 were 
$16.9 million
 and 
$30.4 million
, respectively. Research and development expenses for the same periods ended 
June 30, 2021 were 
$10.3 million
 and 
$20.5 million
, respectively. These increases are the result of the Company’s EMMPACT and Long COVID Phase 2 clinical trials, as well as closure costs for its EMMPOWER Phase 2 clinical trial.

G&A Expenses: General and administrative expenses for the quarter and six months ended 
June 30, 2022 were 
$3.8 million
 and 
$8.5 million
, respectively. General and administrative expenses for the same periods ended 
June 30, 2021 were 
$4.9 million
 and 
$9.2 million
. These decreases are primarily the result of lower non-cash stock-based compensation expenses.

Net Loss: Net loss for the quarter and six months ended 
June 30, 2022 was 
$21.3 million
, or 
$0.40 per basic and diluted share, and 
$40.3 million
, or 
$0.86 per basic and diluted share, respectively. This compares with a net loss of 
$15.9 million
, or 
$0.42 per basic and diluted share, and 
$31.1 million
, or 
$0.83 per basic and diluted share, for the quarter and six months ended 
June 30, 2021.

Internet Posting of
Information

Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, 
Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella
Therapeutics (Nasdaq: AXLA)

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, and non-alcoholic steatohepatitis (NASH). The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Forward-Looking
Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing of the company’s clinical trial data readouts, its expected cash runway and the potential impact of the company’s recent clinical trial data readouts on market interest and acceptance of the company’s product candidates and investment interest in the company’s securities. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the potential impact of COVID-19 on the company’s ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical trials of AXA1125, other potential impacts of COVID-19 on the company’s business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the company’s clinical trial plans and timing, clinical trial design and target indications for AXA1125, the clinical development and safety profile of AXA1125 and its therapeutic potential, whether and when, if at all, the company’s product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the company’s target indications, and other risks identified in the company’s 
SEC filings, including Axcella’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the 
SEC. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220812005033/en/

Ashley Robinson [email protected]
(617) 430-7577

Source: Axcella Therapeutics

 

Friday, August 12, 2022

Onconova Therapeutics (ONTX)
All Trials Continue Toward Data Milestones

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

2Q22 Onconova Reported Trial Progress. 2Q22 loss of $4.0 million or $(0.19) per share, compared with our estimated loss of $3.7 million or $(0.18) per share.  Several clinical trials for both narazaciclib and rigosertib are continuing as expected.  The company ended the quarter with $46.5 million in cash and cash equivalents.

Both Narazaciclib Phase 1/2 Trials Continue To Enroll Patients.  The two trials testing narazaciclib at different treatment schedules continue to treat patients.  The trial in China continues in its fifth cohort while the US trial recently begun dosing its fifth cohort.  Neither trial has reached its maximum tolerated dose and none of the toxicities associated with other CDK4/6 drugs have been reported.  We expect announcement of the dosing level selected for Phase 2 around 4Q22….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Friday, August 12, 2022

Baudax Bio (BXRX)
Baudax Bio reports 2Q 2022; Headwinds Persist

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Baudax Bio, Inc. reported 2Q 2022 results yesterday.  While there was a revenue shortfall ($.3 million vs $.77 million expected), overall operating expenses of $7.8 million were below our estimate of $10.4 million due to lower severance costs primarily accrued in 1Q, and lower COGS and SG&A in 2Q, offset a bit by higher contingent consideration to Alkermes and a slight bump up in R&D from trial initiations. GAAP loss per share in 2Q was $(1.05) vs our expected $(1.27).

Feeling the impact of Covid.  Revenues came in light as Covid-related problems, including staffing shortages, continue to restrict usage at hospitals and ASCs, although 2Q hospital usage increased 12% as compared to 1Q 2022 and 2Q revenues increased 49% compared to the year ago period. Vials sold increased 67%. That said, in certain cases, procedure volumes are running as much as 50% below normal periods and are expected to not fully resolve until next year, at the earliest. An expected ramp in ANJESO is expected to be muted well into 2023….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Schwazze Announces Second Quarter Results

Research, News, and Market Data on Schwazze

Record Quarterly Revenue and Adjusted EBITDA

Revenue Increases 44% to $44.3 Million Compared to $30.7 Million
in Q2 2021

Adjusted EBITDA of $15 Million, 33.9% of Revenue

Revised Guidance Driven by Short-Term, Challenging Colorado
Market Conditions
Q4 2022 Projected Revenue Annualized Run Rate: $175 Million – $200 Million
Q4 2022 Projected Adjusted EBITDA Annualized Run Rate: $60 Million – $72
Million

Conference Call & Webcast Scheduled for Today – 5:00 pm EDT

DENVER, Aug. 11, 2022 /PRNewswire/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), today announced financial results for the second quarter ended June 30, 2022 (“Q2 2022”).

Q2 2022 Financial
Summary:

• Revenues of $44.3 million increased 44% compared to $30.7 million in second quarter ended June 30, 2021 (“Q2 2021”)
• Retail sales were $38.1 million up 77% when compared to Q2 2021
• Gross Margin of $25.2 million was up 69% compared to $14.9 million in Q2 2021, this quarter was affected by $0.2M in purchase accounting
• Net Income was $33.8 million compared to a Net Income of $4.4 million for the same period last year
• Adjusted EBITDA of $15 million was 33.9% of revenue, compared to $10 million for the same period last year
• Colorado two year stacked IDs for Q2 2022 compared to Q2 2021 and Q2 2020 for same store sales⁽¹⁾ were 1.8% and one year IDs⁽¹⁾ were (12.7%) comparing Q2 2022 to Q2 2021
• Average basket size ⁽¹⁾ for Q2 2022 was $59.98 down 4.1% compared to Q2 2021
• Recorded customer visits ⁽¹⁾ for Q2 2022 totaled 444,771 down 8.9%, compared to Q2 2021
• New Mexico two year stacked IDs for Q2 2022 compared to Q2 2021 and Q2 2020 for same store sales⁽¹⁾ were 41.0% and one year IDs⁽¹⁾ were 30.4% comparing Q2 2022 to Q2 2021
• Average basket size ⁽¹⁾ for Q2 2022 was $54.56 down 12.7% compared to Q2 2021
• Recorded customer visits ⁽¹⁾ for Q2 2022 totaled 209,591 up 49.4%, compared to Q2 2021

Accomplishments
Since December 2021, Schwazze has closed acquisitions adding 15 cannabis dispensaries, 10 in New Mexico and five in Colorado as well as four cultivation facilities in New Mexico and one in Colorado and one manufacturing asset in New Mexico.

• Closed Acquisition of Urban Health & Wellness Assets
• Listed Common Stock on the NEO Exchange
• Closed Acquisition of Brow 2 LLC Assets
• Closed Acquisition of Emerald Fields
• Added President of New Mexico Division
• Closed New Mexico Acquisition, Becoming a Regionally Focused MSO
• Added to Key Senior Leadership Team
• Closed Acquisition of Drift Assets

Justin Dye, Chairman and CEO of Schwazze stated
, “Similar to the rest of the country, the cannabis industry in
Colorado is also experiencing a slowdown in growth compared to the last couple
of years. Schwazze, however, is demonstrating that our regional strategy, built
on a customer first approach, developing significant scale, building brands and
leveraging data analytics and technology is not only sound but gaining momentum
as demonstrated by revenue and unit sales growth, customer loyalty and by once
again outpacing the legacy market growth by approximately 12%.  We believe
this model will travel well to other states as we find attractive
opportunities. Despite share price weakness driven by broader market
influences, we remain bullish on our business and have conviction that as
Schwazze continues to deliver superior operating results that our shareholders
will be rewarded.”

Justin continued, “As we look to
the future, we expect continued growth in Colorado and New Mexico through both
organic and inorganic means. Our operations continue to mature and gain
momentum, and we firmly believe that we are winning in our markets. Our team
will continue to focus on growing profitably and generating cash flow from
operations.  When positive federal legislation is passed, Schwazze will be
well-positioned as a market leader to take advantage of banking services and
institutional investment.”

Q2 2022 Revenue
Revenues for the three months ended June 30, 2022, totaled $44.3 million, including (i) retail sales of $38.1 million (ii) wholesale sales of $6.1 million and (iii) other operating revenues of $43,750, compared to revenues of $30.7 million, including (i) retail sales of $21.5 million, (ii) wholesale of $9.2 million, and (iii) other operating revenues of $16,844 during the three months ended June 30, 2021, representing an increase of $13.5 million or 44%. This increase was due to increased sale of our products as well as execution of our growth through acquisition initiatives. In the second quarter of 2022, the Company acquired one additional retail dispensary, which generated additional retail revenue. Additionally, recreational marijuana sales became legal in New Mexico in April 2022, which increased sales volume and revenues in New Mexico. Wholesale revenues in Colorado decreased due to increased cultivation capacity in the state resulting in an over-supply of wholesale cannabis materials.

Cost of goods and services for the three months ended June 30, 2022, totaled $19.1 million compared to cost of services of $15.8 million during the three months ended June 30, 2021, representing an increase of $3.3 million or 21%. The increase in cost of goods is driven by the increase in revenue, however not at the same rate. In the quarter, the Company experienced a reduction in costs driven by vertical integration and third-party price negotiations.

Gross profit increased to $25.2 million for Q2 2022 compared to $14.9 million during the same period in 2021. Gross profit margin increased as a percentage of revenue from 48.5% to 56.8%, and net of purchase accounting, the gross margin increased to 57.4%.  This positive result, net of purchase accounting continues to reflect our consolidated purchasing approach, the implementation of our retail playbook, and vertical product sales in New Mexico.

Operating expenses for the three months ended June 30, 2022, totaled $16.1 million, compared to operating expenses of $10.5 million during the three months ended June 30, 2021, representing an increase of $5.6 million or 54%. This increase is due to increased selling, general and administrative expenses, professional service fees, salaries, benefits, and related employment costs driven by growth from acquisitions.

Other income for the three months ended June 30, 2022, totaled $29.2 million compared to $0.2 million during the three months ended June 30, 2021, representing an increase in income of $29 million or 18,435%. The increase in other income is due to the revaluation of the derivative liability related to the Investor Notes, offset by higher interest payments.

The Company generated net income for the three months ended June 30, 2022, of $33.8 million, compared to net income of $4.4 million for the three months ended June 30, 2021.

Adjusted EBITDA for Q2 2022 was $15 million representing 33.9% of revenue, compared to $10 million and 32.6% of revenue for the same period last year. This is derived from Operating Income and adjusting one-time expenses, merger and acquisition and capital raising costs, non-cash related compensation costs, and depreciation and amortization. See the financial table for Adjusted EBITDA below adjustment for details. 

For six months ending June 30, 2022, the Company used cash for operations of ($8.0) million compared to generating cash of $1.4 million for the same period in 2021.  The Company has cash and cash equivalents of $33.9 million at the end of Q2 2022. 

Nancy Huber, CFO for Schwazze commented, ”
During Q2 we focused on completing integration of our acquisitions and
made sure that we used our resources effectively. We are focused on reducing
operating and SG&A expenses and judiciously investing growth capital to
ensure adequate liquidity and profitability despite difficult market conditions
in Colorado, which we believe to be transitory and temporary. Our balance sheet
remains strong, and we have ample liquidity.  We are focused on delivering
positive cash flow net of acquisition costs for the year while driving organic
growth and making smart acquisitions.”

2022 Guidance

The Company has revised its guidance for a fourth-quarter 2022 (Q4 2022) annualized run rate, which excludes transactions that are announced but not closed.  Q4 2022 revenue annualized run rate is projected to be $175 million to $200 million, and the Q4 2022 adjusted EBITDA annualized run rate is projected to be from $60 million to $72 million.  

NOTES:

(1)  Schwazze did not own all the assets and entities in part of 2021, 2020 and 2019 and is using unaudited numbers for this comparison.

Adjusted EBITDA represents income (loss) from operations, as reported, before
tax, adjusted to exclude non-recurring items, other non-cash items, including
stock-based compensation expense, depreciation, and amortization, and further
adjusted to remove acquisition and capital raise related costs, and other
one-time expenses, such as severance, retention, and employee relocation. The
Company uses adjusted EBITDA as it believes it better explains the results of
its core business. The Company has not reconciled guidance for adjusted EBITDA
to the corresponding GAAP financial measure because it cannot provide guidance
for the various reconciling items. The Company is unable to provide guidance
for these reconciling items because it cannot determine their probable
significance, as certain items are outside of its control and cannot be
reasonably predicted. Accordingly, a reconciliation to the corresponding GAAP
financial measure is not available without unreasonable effort.

Webcast – August 11,
2022 – 5:00 PM EDT
Investors and stakeholders may participate in the conference call by dialing 416 764 8650 or by dialing North American toll free 1-888-664-6383 or listen to the webcast from the Company’s website at https://ir.schwazze.com The webcast will be available on the Company’s website and on replay until August 18, 2022, and may be accessed by dialing 1-888-390-0541 / # 575833

Following their prepared remarks, Chief Executive Officer, Justin Dye and Chief Financial Officer, Nancy Huber will answer investor questions. Investors may submit questions in advance or during the conference call itself through the weblink: https://app.webinar.net/lwXbZbBZmKN  This weblink has been posted to the Company’s website and will be archived on the website. All Company SEC filings can also be accessed on the Company website at https://ir.schwazze.com/sec-filings

About Schwazze
Schwazze (OTCQX: SHWZ, NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious practices. Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking
Statements
Such forward-looking statements may be preceded by the words “plan,” “will,” “may,” “continue,” “anticipate,” “become,” “build,” “develop,” “expect,” “believe,” “poised,” “project,” “approximate,” “could,” “potential,” or similar expressions as they relate to Schwazze. Forward-looking statements include the guidance provided regarding the Company’s Q4 2022 performance and annual capital spending. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and New Mexico and outside the states, (vii) our ability to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, (x) the timing and extent of governmental stimulus programs, (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and (xii) our ability to achieve the target metrics, including our annualized revenue and EBIDTA run rates set out in our Q4 2022 guidance. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

 View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-announces-second-quarter-results-301604597.html

SOURCE Schwazze

Released August 11,
2022

 

Onconova Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

News and Market Data on Onconova Therapeutics

Conference call and live webcast at 4:30 p.m. ET today

NEWTOWN, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended June 30, 2022, and provided a business update.

Highlights for the second quarter of 2022 and recent weeks include:

• Safety data from the ongoing Phase 1 solid tumor trials of narazaciclib in the United States and China continue to be encouraging with the maximum tolerated dose not yet reached in either study. The trial in the United States is currently enrolling its fifth dose escalation cohort, with continuous dosing. The trial in China is also enrolling its fifth dose escalation cohort but once a day on days 1-21 of 28-day cycles. A protocol amendment to enable further dose escalation in the trial in China is being prepared.
• Data from 
  in
  vitro and cell-based assays that suggest narazaciclib’s inhibitory profile may provide safety and efficacy advantages over currently approved CDK4/6 inhibitors were featured in an abstract published at the American Society of Clinical Oncology (ASCO) Annual Meeting.
• Each of rigosertib’s investigator-sponsored trials continues to progress. A Phase 2 trial evaluating rigosertib plus pembrolizumab in patients with checkpoint inhibitor refractory metastatic melanoma is on schedule to be initiated in the second half of 2022. The expansion cohort of the Phase 1/2a trial of rigosertib plus nivolumab in patients with KRAS-mutated non-small cell lung cancer continues to enroll patients, with additional data from the trial expected in Q3 2022. The Phase 2 trial of rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa also continues to enroll patients.
• Mark Guerin was appointed Chief Operating Officer in addition to his role as Chief Financial Officer and Dr. Adar Makovski Silverstein was promoted to Senior Director and Head of Corporate Development.
• Cash and cash equivalents at June 30, 2022 were $46.5 million, which the Company believes will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Management Commentary

“We saw sustained progress across our pipeline over the past months and are well positioned to complete our current Phase 1 trials as we move through the second half of the year,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “Narazaciclib continues to show a favorable safety profile in its Phase 1 studies, which will be key to informing the design of future trials seeking to address the unmet needs posed by the limitations of currently available CDK4/6 inhibitors. These limitations stem from issues related to safety, tolerability, and primary and acquired drug resistance, which we believe narazaciclib’s differentiated inhibitory profile may overcome. We were pleased to publish preclinical data supporting this hypothesis at the most recent ASCO meeting and look forward to continued efforts to translate these promising findings to the clinic.”

Dr. Fruchtman continued, “Alongside narazaciclib’s advancement, we also made key progress in rigosertib’s investigator-sponsored studies. This includes a Phase 2 trial evaluating rigosertib combined with a PD-1 checkpoint inhibitor in checkpoint inhibitor refractory metastatic melanoma which is on schedule to open for enrollment in the second half of 2022. This study seeks to leverage rigosertib’s immunomodulatory effects and is supported by initial data from the ongoing trial of rigosertib plus anti-PD-1 therapy in KRAS-mutated NSCLC. These data provided strong evidence of the studied doublet’s activity in patients who previously failed checkpoint inhibitor therapy, which is a finding we aim to build upon with the presentation of additional data at a medical meeting later this quarter. Data has been presented, which will be updated, demonstrating that responses seen with rigosertib in this setting are agnostic to the type of KRAS mutation present. This upcoming milestone highlights how rigosertib’s investigator-sponsored studies enable the capital efficient pursuit of value creating opportunities to complement our lead narazaciclib program.”

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2022, were $46.5 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Research and development expenses were $2.0 million for the second quarter of 2022, compared with $1.9 million for the second quarter of 2021.

General and administrative expenses were $2.1 million for the second quarter of 2022, compared with $2.9 million for the second quarter of 2021.

Net loss for the second quarter of 2022 was $4.0 million, or $0.19 per share on 20.9 million weighted shares outstanding, compared with a net loss of $4.2 million, or $0.27 per share for the second quarter of 2021 on 15.8 million weighted shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the second quarter of 2022, provide a business update, and answer questions. Interested parties can participate by dialing (800) 289-0571 (domestic callers) or (856) 344-9290 (international callers) and using conference ID 3600715.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680

[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200

[email protected]

 

ONCONOVA
THERAPEUTICS, INC.

Condensed
Consolidated Balance Sheets

(in
thousands)

	June 30				December 31,
		2022				2021
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	46,533			$	55,070
Receivables		28				28
Prepaid expenses and other current assets		1,472				332
Total current assets		48,033				55,430
Property and equipment, net		31				38
Other non-current assets		10				10
Total assets	$	48,074			$	55,478
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,003			$	2,757
Accrued expenses and other current liabilities		3,231				3,132
Deferred revenue		226				226
Total current liabilities		6,460				6,115
Deferred revenue, non-current		3,130				3,243
Total liabilities		9,590				9,358
Stockholders’ equity:
Preferred stock		–				–
Common stock		209				209
Additional paid in capital		491,181				490,644
Accumulated other comprehensive loss		(41	)			(14	)
Accumulated deficit		(452,865	)			(444,719	)
Total stockholders’ equity		38,484				46,120
Total liabilities and stockholders’ equity	$	48,074			$	55,478

 

ONCONOVA
THERAPEUTICS, INC.

Condensed
Consolidated Statements of Operations

(in
thousands, except share and per share amounts)

	Three Months Ended June 30,								Six months months ended June 30,
		2022				2021				2022				2021
Revenue	$	57			$	57			$	113			$	113
Operating expenses:
General and administrative		2,139				2,850				4,325				5,067
Research and development		2,038				1,852				4,040				3,789
Total operating expenses		4,177				4,702				8,365				8,856
Loss from operations		(4,120	)			(4,645	)			(8,252	)			(8,743	)
Change in fair value of warrant liability		–				427				–				(209	)
Other income (loss,) net		96				(13	)			106				6
Net loss		(4,024	)			(4,231	)			(8,146	)			(8,946	)
Net loss per share of common stock, basic and diluted	$	(0.19	)		$	(0.27	)		$	(0.39	)		$	(0.59	)
Basic and diluted weighted average shares outstanding		20,904,085				15,780,863				20,904,085				15,201,719

 

 

Lineage Cell Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

Research, News, and Market Data on Lineage Cell Therapeutics

• Advanced RG6501 (OpRegen^®)
  Development in Partnership with Roche and Genentech
• Published OPC1 Phase 1/2a Clinical Study
  Results in Journal of Neurosurgery: Spine
• Completed Key Activities to Support Planned
  Regulatory Interactions for OPC1 and VAC2
• Expanded Collaboration with Advanced BioMatrix
  for HyStem^® Cell Drug Delivery Technology
• Cash, Cash Equivalents, and Marketable
  Securities of $72.0 Million as of June 30,
  2022 Expected to Provide Capital Through Q2 2024

CARLSBAD, Calif.–(BUSINESS WIRE)–Aug. 11, 2022– Lineage Cell
Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the second quarter of 2022. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.

“We are pleased with the progress on RG6501 (OpRegen) product development under our collaboration with Roche and Genentech. During the second quarter this year, we have made progress across multiple functional areas, including clinical, regulatory, and technology transfer activities,” stated Brian M. Culley, Lineage CEO. “As we continue to position Lineage as a leader in regenerative medicine through the transplant of specific cell types, our focus is on completing the necessary clinical, regulatory and related activities which can create value and reduce risk across our portfolio of five cell transplant assets. In particular, our efforts have been focused on preparing for OPC1 and VAC2 regulatory interactions to enable their next phases of clinical testing in spinal cord injury and oncology, respectively. In parallel, we are advancing our auditory neuron and photoreceptor programs through preclinical development activities which are necessary to support initial clinical testing. We believe our disciplined use of capital and our increased strategic business development activities can support multiple years of growth and the achievement of important milestones in the months and years to come.”

Second quarter milestones and activities included:

– RG6501 (OpRegen)

• Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including:
  • Conducting additional OpRegen manufacturing runs and supporting Chemistry Manufacturing and Controls (CMC) activities.
  • Continuing technology transfer activities.
  • Actively participating in both Joint Advisory and Joint Manufacturing Committees, forums for discussion and planning with respect to next steps in clinical development and related activities.
• Continuing long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
  • Enrolled patients have continued to do well, supporting multi-year durability of a treatment effect with RG6501 (OpRegen).

– OPC1

• Results from a Phase 1/2a clinical study in subacute cervical spinal cord injury were 
  published in the 
  Journal of Neurosurgery: Spine;
  • OPC1 has demonstrated an excellent safety profile, and at one-year post-treatment, 96% of patients had recovered one or more levels of neurological function on at least one side of their body, and 32% of patients had recovered two or more levels of neurological function on at least one side of their body.
• Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, has demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation.
• A majority of the verification and validation activities for the novel parenchymal spinal delivery (PSD) system, and its preclinical testing in support of a regulatory submission have been completed.
• Preclinical activities to support upcoming regulatory interactions are near completion.
• Engagement with the California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates, is underway.

– VAC2

• Following technology transfer of the program from Cancer Research UK (CRUK) to Lineage and improvement of manufacturing processes, production scale was increased and accordingly the cost of goods has been reduced significantly, along with marked improvements in the purity and functionality of the manufactured material.
• CRUK continues to follow patients on the Phase 1 NSCLC clinical study; Lineage has received all necessary clinical information from CRUK required to support U.S., or other, regulatory interactions.

– ANP1 & PNC1

• Preclinical activities are continuing, including thought leader engagement to support future preclinical testing.

– Business Development

• Broadened collaboration with Advanced BioMatrix, a division of BICO Group AB (STO: BICO), for the HyStem delivery technology to include clinical/commercial GMP (Good Manufacturing Practice) material, increasing the milestone payments and royalty percentages due to Lineage upon ABM reaching certain development milestones and/or product sales.
• Continued work under our collaboration with our strategic partner, Immunomic Therapeutics (“ITI”); currently awaiting decision on next steps for ITI’s allogeneic cell-based cancer immunotherapy for the treatment of glioblastoma based on the VAC platform.

Some of the key upcoming milestones and activities anticipated
by Lineage include:

– Planned interaction with FDA in Q4 2022 to discuss an OPC1 IND amendment submission to enable clinical performance and safety testing of a novel PSD system.

– A pre-IND regulatory interaction in Q4 2022 to seek feedback on a VAC2 CMC, nonclinical, and clinical package to support U.S. clinical development; pre-IND briefing package submission in Q3 2022.

– Submission of a grant application to the California Institute for Regenerative Medicine (CIRM) for the continued support of the clinical development of OPC1.

– Clinical data update from the ongoing VAC2 Phase 1 non-small cell lung cancer (NSCLC) study, pending release from CRUK.

– Preclinical activities for both the ANP1 and PNC1 programs.

– Additional OPC1 publications, including preclinical study results utilizing a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process.

– An additional OPC1 manuscript from a Phase 1/2a clinical study in subacute cervical spinal cord injury, focused on MRI data.

– Evaluation of new partnership opportunities and/or expansion of existing collaborations.

– Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission and accomplishments.

Balance Sheet Highlights

Cash, cash equivalents, and marketable securities totaled $72 million as of June 30, 2022, which is expected to support operations through Q2 2024.

Second Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues for the three months ended June 30, 2022 were approximately $4.6 million, a net increase of $4.0 million as compared to $0.5 million for the same period in 2021. The increase was primarily related to licensing fees recognized from deferred revenues in connection with the $50.0 million upfront licensing payment received in the first quarter of 2022 from Roche.

Operating Expenses: Operating expenses are comprised of research and development (“R&D”) expenses and general and administrative (“G&A”) expenses. Total operating expenses for the three months ended June 30, 2022 were $8.6 million, an increase of $1.1 million as compared to $7.5 million for the same period in 2021.

R&D Expenses: R&D expenses for the three months ended June 30, 2022 were $3.3 million, a net increase of $0.4 million as compared to $2.9 million for the same period in 2021. The net increase was driven by $0.1 million in higher OpRegen related expenses to support the Roche Collaboration. Another $0.2 million and $0.1 million of the increase was related to R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.

G&A Expenses: G&A expenses for the three months ended June 30, 2022 were $5.3 million, a net increase of approximately $0.7 million as compared to $4.5 million for the same period in 2021. The increase was primarily attributable to $0.4 million in payroll and related benefits expense, and $0.5 million in share-based compensation, partially offset by $0.2 million in lower investor relations expense.

Loss from Operations: Loss from operations for the three months ended June 30, 2022 was $4.2 million, a decrease of $2.9 million as compared to $7.1 million for the same period in 2021.

Other Income/(Expenses), Net: Other income (expenses), net for the three months ended June 30, 2022 reflected other expense, net of ($2.5) million, compared to other income, net of $2.1 million for the same period in 2021. The net change was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries, as well as a decrease in the value of marketable equity securities, and partially offset by the gain on extinguishment of debt from Lineage’s Paycheck Protection Program loan forgiveness recognized in the prior year’s quarter.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2022 was $6.8 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $4.8 million, or $0.03 per share (basic and diluted), for the same period in 2021.

Conference Call and Webcast

Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the “Lineage Cell Therapeutics Call” or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our ability to support our operations for at least two years with our existing cash, cash equivalents and marketable securities; our ability to create value and reduce risk across our portfolio; our ability to support multiple years of progress and achieve important milestones; our collaboration and license agreement with Roche and Genentech and the potential to receive milestone and other consideration thereunder; the potential benefits of treatment with OpRegen; the potential future achievements of our clinical and preclinical programs; the timing of anticipated FDA interactions, preclinical activities, clinical trials, and clinical data updates related to our programs, and the submission of a grant application to the CIRM; plans and expectations regarding publications relating to our programs; plans and expectations regarding potential new partnership opportunities and existing collaborations; our ability to broaden awareness of our mission and accomplishments; plans and expectations regarding our products in development. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005126/en/

 

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(
[email protected])
(442) 287-8963

Russo Partners – Media Relations
Nic Johnson or David Schull
[email protected]
[email protected]
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

 

Baudax Bio Reports Second Quarter 2022 Financial Results and Business Highlights

Research, News, and Market Data on Baudax Bio

August 11, 2022 7:00am EDT

ANJESO^® Net Product Revenue Up 49% Year-Over-Year;
Vials Sold to End-Users Up 67% Year-Over-Year

Dosing Complete in the First Cohort of the Phase I BX2000 Study;
On Track to Complete Enrollment in Remaining Cohorts by Early 2023

MALVERN, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for acute care settings, today reported financial results for the three and six months ended June 30, 2022, provided key metrics around the ongoing commercialization of ANJESO (meloxicam) injection, updated status of the neuromuscular blocking (NMB) agent development program, and provided an overview of other corporate and financial developments.

“ANJESO continued its solid sales performance during the second quarter of 2022 with 49% growth year-over-year,” said Gerri Henwood, President and CEO of Baudax Bio. “The development programs for our neuromuscular blocking (NMB) agents continue to advance with the commencement of a Phase I clinical study evaluating BX2000, our ultra-short acting NMB, in healthy volunteers. We are on track to progress through the remaining dosing cohorts and expect to complete enrollment of the study by early 2023. We are also working toward initiation of a Phase II study evaluating our intermediate-acting NMB, BX1000, in surgical patients and we look forward to keeping you updated on our progress.”

Second Quarter 2022 and
Recent Business Highlights

ANJESO

• ANJESO
  U.S. Commercialization. ANJESO is indicated for the management of moderate to severe pain in adults, alone or in combination with other non-NSAID analgesics. For the second quarter of 2022, ANJESO achieved net product revenue of $0.3 million, reflecting 49% growth year-over-year. Vials sold to end-users increased by approximately 67% compared to the same prior year period. In terms of site of care usage of ANJESO, there was a 12% increase in vials sold to hospitals in the second quarter of 2022 compared to the first quarter of 2022. In the second quarter of 2022 the re-order rate from existing accounts was 72%.  

• Impacts
  from COVID-19. The newer Omicron variants of COVID-19 as well as hospital and ambulatory surgical center staffing issues, although beginning to stabilize, continued to impact the number of elective surgeries performed during the quarter. Cancellations of elective surgeries were primarily due to patients or ASC and hospital staff testing positive for COVID-19, as well as reduced availability of staff at ambulatory surgical centers and hospitals.

NMBs

• BX1000
  (IV Intermediate-action). A dose-escalation Phase I study evaluating BX1000 in 58 healthy volunteers was completed and results showed that BX1000 was generally well tolerated through the dosing range tested. Muscle paralysis was rapidly achieved along with complete spontaneous recovery. Baudax Bio is preparing the clinical study report for this dose-escalation study and expects to submit it to the U.S. Food and Drug Administration (FDA) in 2022. Additionally, the Company expects to begin enrollment in a Phase II study in surgical patients during 2022.

• BX2000
  (IV Ultra-short action). Dosing was completed for the first cohort of the Phase I dose escalation study evaluating the safety, tolerability and pharmacokinetics of BX2000 in healthy volunteers. This study is comprised of up to 10 dosing cohorts and each cohort is planned to enroll 8 patients. The Company expects to complete enrollment of the remaining cohorts in the study by early 2023.

• BX3000
  (Reversal agent). Additional work to enhance the formulation of the BX3000 reversal agent is complete and the Company believes this data, along with certain non-clinical data, which will be submitted to FDA by early 2023, will support and IND filing for a Phase I study in healthy volunteers the first half of 2023.

Corporate and Financial

• Secured
  $2.0 Million in Financing. In May, Baudax Bio completed a registered direct offering with institutional investors securing approximately $2.0 million, before deducting placement agent fees and other offering expenses. The financing was priced at-the-market and the Company issued and sold approximately 1.6 million shares of its common stock, at a purchase price of $1.215 per share. The Company also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to 1.6 million shares of its common stock.

Second Quarter 2022
Financial Results

As of June 30, 2022, Baudax Bio had cash and cash equivalents of $5.2 million.

Net product revenue related to sales of ANJESO in the U.S., recognized according to U.S. GAAP, for the three months ended June 30, 2022 was $0.3 million. This compares to $0.2 million for the three months ended June 30, 2021, an increase of $0.1 million, or 49%, despite a decrease of approximately 80% of the field staff in the current year. While utilizing the title model of distribution, product revenue is recognized as shipments are made to the Company’s third-party logistics provider. The increase in net product revenue was attributable to increased demand at existing accounts as well as securing additional formulary approvals.

Cost of sales for the three months ended June 30, 2022 was $0.4 million, compared to $0.6 million for the three months ended June 30, 2021, a decrease of $0.2 million, and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. The decrease of $0.2 million was primarily a result of the reduction in manufacturing costs, including production and storage costs, in the current year compared to the prior year. Certain product costs of ANJESO units recognized as revenue during the three months ended June 30, 2022 and 2021 were expensed prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the related periods. Baudax Bio expects that over time, product costs in cost of sales will modestly increase as sales increase and inventory associated with the units manufactured prior to FDA approval have been sold.

Research and development expenses for the three months ended June 30, 2022 and 2021 were $0.9 million.

Selling, general and administrative expenses for the three months ended June 30, 2022 were $4.0 million, of which $1.1 million was attributable to selling expense and $2.9 million was attributable to general and administrative expense. This compares to $10.6 million for the same prior year period, of which $5.0 million was attributable to selling expense and $5.6 million was attributable to general and administrative expense. Selling expenses decreased $3.9 million, primarily as a result of a reduction in personnel costs of $2.4 million and a decrease in marketing costs of $1.4 million. The decrease of $2.7 million in general and administrative costs was primarily a result of a decrease in personnel costs of $1.4 million, a decrease in public company costs of $0.9 million and a decrease in consulting costs of $0.3 million.

Baudax Bio reported a net loss of $7.5 million, or $(1.05) per share, including non-cash charges of $2.6 million, for the three months ended June 30, 2022. Adjusted net loss* was $4.9 million.

Six Months Ended June
30, 2022 Financial Results

Net product revenue related to sales of ANJESO in the U.S., recognized according to U.S. GAAP, for the six months ended June 30, 2022 was $0.7 million. This compares to $0.4 million for the six months ended June 30, 2021, an increase of $0.3 million. While utilizing the title model of distribution, product revenue is recognized as shipments are made to the Company’s third-party logistics provider. The increase in net product revenue was attributable to increased demand at existing accounts as well as securing additional formulary approvals.

Cost of sales for the six months ended June 30, 2022 was $1.0 million, compared to $1.4 million for the six months ended June 30, 2021, a decrease of $0.4 million, and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. The decrease of $0.4 million was primarily a result of the reduction in scrap expense recorded in the current year compared to the prior year of $0.2 million and a decrease in manufacturing costs, including reductions in production and storage costs, of $0.2 million. Certain product costs of ANJESO units recognized as revenue during the six months ended June 30, 2022 and 2021 were expensed prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the related periods. Baudax Bio expects that over time, product costs in cost of sales will modestly increase as sales increase and inventory associated with the units manufactured prior to FDA approval have been sold.

Research and development expenses for the six months ended June 30, 2022 were $2.2 million compared to $2.0 million for the six months ended June 30, 2021. The increase of $0.2 million was primarily due to the initiation of the pediatric trial for ANJESO of $0.2 million.

Selling, general and administrative expenses for the six months ended June 30, 2022 were $18.2 million, of which $8.3 million was attributable to selling expense and $9.9 million was attributable to general and administrative expense. This compares to $22.7 million for the same prior year period, of which $10.1 million was attributable to selling expense and $12.6 million was attributable to general and administrative expense. Selling expenses decreased $1.8 million, primarily as a result of a decrease in marketing costs of $1.1 million and a reduction in personnel costs of $0.7 million. The decrease of $2.7 million in general and administrative was primarily a result of a decrease in public company costs of $1.4 million, a decrease in personnel costs of $0.9 million and a decrease in consulting costs of $0.4 million.

Baudax Bio reported net loss of $20.3 million, or $(3.63) per share, including net non-cash charges of $0.2 million, for the six months ended June 30, 2022. Adjusted net loss* was $20.1 million.

* Non-GAAP Financial
Measures

To supplement the Company’s financial results determined by U.S. generally accepted accounting principles (“GAAP”), the Company is reporting certain non-GAAP information for its business, including adjusted net loss. Adjusted net loss is net loss as determined under GAAP, excluding the changes in fair values of contingent consideration and warrant valuations, gain on extinguishment of debt, interest, depreciation, amortization, and stock-based compensation. The Company believes this non-GAAP financial measure is helpful in understanding its business as it is useful to investors in allowing for greater transparency of supplemental information used by management. This measure is used by investors, as well as management in assessing the Company’s performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. Please see the section of this press release titled “Reconciliation of GAAP to Non-GAAP Financial Measures” for a reconciliation of non-GAAP adjusted net loss to its most directly comparable GAAP measure.

About ANJESO^®

ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO^®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Forward Looking
Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including statements relating to future expenses, product costs, and the development of each of BX1000, BX2000, and BX3000, and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACTS:

Investor Relations
Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
[email protected]

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
[email protected]

BAUDAX BIO, INC.
Consolidated Balance Sheets
(Unaudited)
(amounts in thousands, except share and per share data)
Assets									June 30, 2022			December 31, 2021
Current assets:
	Cash and cash equivalents							$	5,210		$	15,891
	Accounts receivable, net								616			542
	Inventory								5,255			5,002
	Prepaid expenses and other current assets								1,398			2,059
					Total current assets			$	12,479		$	23,494
	Property, plant and equipment, net								4,941			5,015
	Intangible assets, net								20,390			21,678
	Goodwill								2,127			2,127
	Other long-term assets								897			963
					Total assets			$	40,834		$	53,277
Liabilities and Shareholders’ Equity
Current liabilities:
	Accounts payable								3,064			1,468
	Accrued expenses and other current liabilities								3,812			5,540
	Current portion of long-term debt, net								3,611			2,222
	Current portion of contingent consideration								7,694			6,416
					Total current liabilities				18,181			15,646
	Long-term debt, net								5,099			6,309
	Long-term portion of contingent consideration								12,692			17,446
	Other long-term liabilities								632			650
					Total liabilities				36,604			40,051
Shareholders’ equity:
	Preferred stock, $0.01 par value. Authorized, 10,000,000 shares;
		none issued and outstanding.							—			—
	Common stock, $0.01 par value. Authorized, 190,000,000 shares; issued and outstanding, 8,068,853 shares at June 30, 2022 and 2,807,239 shares at December 31, 2021								81			28
	Additional paid in-capital								156,578			145,287
	Accumulated deficit								(152,429	)		(132,089	)
					Total shareholders’ equity				4,230			13,226
					Total liabilities and shareholders’ equity			$	40,834		$	53,277

 

BAUDAX BIO, INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(amounts in thousands, except share and per share data)
						Three Months Ended						Six Months Ended
						June 30,						June 30,
						2022			2021			2022			2021
Revenue, net					$	300		$	201		$	722		$	399
Operating expenses:
	Cost of sales (excluding amortization of intangible assets)					361			586			1,009			1,407
	Research and development					912			857			2,205			1,965
	Selling, general and administrative					4,029			10,608			18,219			22,696
	Amortization of intangible assets					644			644			1,288			1,288
	Change in warrant valuation					(1	)		(59	)		(6	)		(41	)
	Change in contingent consideration valuation					1,327			3,881			(2,476	)		5,722
		Total operating expenses				7,272			16,517			20,239			33,037
		Operating loss				(6,972	)		(16,316	)		(19,517	)		(32,638	)
Other expense:
	Other (expense) income, net					(559	)		987			(823	)		397
	Net loss				$	(7,531	)	$	(15,329	)	$	(20,340	)	$	(32,241	)
Per share information:
Net loss per share of common stock, basic					$	(1.05	)	$	(7.17	)	$	(3.63	)	$	(16.43	)
Net loss per share of common stock, diluted					$	(1.05	)	$	(7.18	)	$	(3.63	)	$	(16.43	)
Weighted average common shares outstanding, basic						7,181,640			2,137,191			5,610,037			1,962,655
Weighted average common shares outstanding, diluted						7,181,640			2,138,100			5,610,037			1,962,655

BAUDAX BIO, INC.
Reconciliation of GAAP to Non-GAAP Measures
(Unaudited)

		For the Three Months Ended June 30,								For the Six Months Ended June 30,
(amounts in thousands)			2022				2021				2022				2021
Net loss (GAAP)		$	(7,531	)		$	(15,329	)		$	(20,340	)		$	(32,241	)
Stock-based compensation			337				903				858				3,207
Non-cash interest expense			223				229				449				458
Gain on extinguishment of debt			—				(1,553	)			—				(1,553	)
Depreciation expense			43				63				86				149
Amortization expense			644				644				1,288				1,288
Non-cash loss on retirement of fixed assets			8				—				8				—
Change in warrant valuation			(1	)			(59	)			(6	)			(41	)
Change in contingent consideration valuation			1,327				3,881				(2,476	)			5,722
Adjusted net loss (non-GAAP)		$	(4,950	)		$	(11,221	)		$	(20,133	)		$	(23,011	)

To supplement the Company’s financial results determined by U.S. generally accepted accounting principles (“GAAP”), the Company has disclosed in the tables below the following non-GAAP information about adjusted net loss.

Adjusted net loss is net loss as determined under GAAP, excluding the changes in fair values of contingent consideration and warrant valuations, gain on extinguishment of debt, interest, depreciation, amortization, and stock-based compensation.

The Company believes that non-GAAP financial measures are helpful in understanding its business as it is useful to investors in allowing for greater transparency of supplemental information used by management. Adjusted net loss is used by investors, as well as management in assessing the Company’s performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.

 

Source: Baudax Bio, Inc.

Released August 11, 2022

Avivagen Announces Receipt of Repeat Order from Asian Customer

Research, News, and Market Data on Avivagen

Ottawa, ON /Business Wire/ August 11, 2022 /– Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce that one of its most important customers in Asia has placed a new order for four tonnes of OxC-Beta™ Livestock to be used in Asia, in line with previous shipments fulfilled in 2021. “It’s encouraging to see one of our largest customers in Asia continue to place sizeable orders – which we view as a sign that they remain on target for economic recovery at a time where uncertainty is playing out elsewhere and also confirms the value of our product in economically challenging times,” says Kym Anthony, Chief Executive Officer of Avivagen Inc. “We are excited for the year ahead as we continue to build on existing and new relationships both in Asia and markets worldwide.” About Avivagen Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release. About OxC-beta™ Technology and OxC-beta™ Livestock Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, Vietnam and Malaysia. Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics. Forward Looking Statements This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s outlook, Avivagen’s expectation that it will fulfill the order described above, the future growth and prospects for Avivagen and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, worldwide demand for products sold by Avivagen may drop, orders may be cancelled, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. For more information: Avivagen Inc. Drew Basek Director of Investor Relations 100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733 E-mail: [email protected] Kym Anthony Chief Executive Officer 100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164 Website: www.avivagen.com Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

 

PsyBio Therapeutics Expands International Patent Applications

Research, News, and Market Data on PsyBio

PsyBio is continuing to increase its psycho-targeted patent
portfolio, executing on its strategic priorities of innovation, development,
and technology optimization

PsyBio now has twenty patent applications in total

OXFORD, Ohio and DENVER, Aug. 8, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company focused upon discovery and development of novel, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today is announcing the filing of additional international patent applications in Europe, Africa, and Asia. This brings PsyBio’s total number of patent application submissions to twenty, making it one of the most robust portfolios in the sector.PsyBio Logo (CNW Group/PsyBio Therapeutics Corp.)

“Biosynthetic tryptamine production allows the development of psycho-targeted molecules as novel therapeutic candidates, with the goal to potentially help improve human health,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “Our IP strategy fosters the developmental processes and will allow us to develop these molecules as smoothly and rapidly as possible. Global patent submissions further expand PsyBio’s IP portfolio and support our ongoing plans for growth.”

The patent applications submitted comprise advancements concerning production methodology, host strains and processes of production that support and allow PsyBio’s novel production methodology to be globally protected. These filings demonstrate the Company’s commitment to value creation, while also promoting scientific and methodologic advancements in the field.

“PsyBio is dedicated to leading the development of psycho-targeted therapeutic candidates in our vision to potentially improve mental and neurological health,” stated Evan Levine, PsyBio’s Chief Executive Officer. “With these additional patent submissions, PsyBio continues to demonstrate its leadership in the biosynthetic development field by prioritizing intellectual property protection, which is necessary for us to achieve our business objectives and important for our current and future investors.”

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof.  The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to build and protect its intellectual property portfolio of novel drug candidates; the ability of PsyBio to launch clinical trials; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file one or more investigational new drug applications with the United States Food and Drug Administration (“FDA“); PsyBio will be successful in obtaining all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (the “TSXV“) has
neither approved nor disapproved the contents of this news release. Neither the
TSXV nor its Regulation Services Provider (as that term is defined in the
policies of the TSXV) accepts responsibility for the adequacy or accuracy of
this release.

SOURCE PsyBio Therapeutics Corp.